NCT01286454

Brief Summary

This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 9, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

December 3, 2010

Results QC Date

December 1, 2011

Last Update Submit

January 24, 2012

Conditions

Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency

Keywords

BIOAVAILABILITYFOOD EFFECT

Outcome Measures

Primary Outcomes (3)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])

    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

  • Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Secondary Outcomes (2)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

  • Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Study Arms (6)

A

EXPERIMENTAL

4 mg fesoterodine IR beads in capsule under fasting condition

Drug: fesoterodine

B

EXPERIMENTAL

4 mg fesoterodine 10% coated ER beads in capsule under fasting condition

Drug: fesoterodine

C

EXPERIMENTAL

4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.

Drug: fesoterodine

D

EXPERIMENTAL

4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.

Drug: fesoterodine

E

EXPERIMENTAL

4 mg fesoterodine ER tablets under fasting condition.

Drug: fesoterodine

F

EXPERIMENTAL

4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.

Drug: fesoterodine

Interventions

fesoterodineDRUG

single dose of beads in capsule

A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years

You may not qualify if:

  • Evidence or history of clinically significant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

January 31, 2011

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 26, 2012

Results First Posted

January 9, 2012

Record last verified: 2012-01

Locations

US(1)